Indian biotech firm Mylab Discovery Solutions on Wednesday announced the launch of a strip-based, rapid point of care test for patients with Sickle Cell Anaemia — a genetic blood disorder — that can detect the disease in a few minutes.
The test comes as the Indian government aims to eliminate the disease by 2047.
The disease often causes red blood cells (RBCs) to become sickle-shaped through the presence of the abnormal haemoglobin S variant. Highly rigid sickle-shaped blood cells can block blood flow and lead to pain and organ damage and can also result in morbidity and mortality.
Approved by the Central Drugs Standard Control Organisation (CDSCO), the PathoCatch Sickle Cell rapid test can detect the presence of abnormal haemoglobin in a small blood sample within a few minutes, the company said in a statement.
Unlike the traditional methods, which are laborious and involve a time-consuming process of collecting blood samples, and transporting it to a lab, the new test can be used easily by healthcare professionals without the use of laboratory equipment.
The test is made up of three indicators, which detect the presence of haemoglobin A, S and C, allowing the user to rapidly distinguish between normal, carrier and sickle cell samples. It has a both combined sensitivity and specificity of 100 per cent, making it one of the fastest and most accurate tests in India.
“The public health implications of Sickle Cell Anaemia are significant as people who have the disease face potentially life-threatening medical complications. Timely diagnostic testing and comprehensive care can significantly reduce morbidity and mortality from the disease,” said Hasmukh Rawal, MD & Co-founder, Mylab, in the statement.
“We are confident that the PathoCatch Sickle Cell Rapid Test will help reduce the burden of Sickle Cell Anaemia in our country and support the government’s mission to eliminate the diseases by 2047,” he added.
Sickle Cell Anaemia is a public health challenge as India is estimated to have the second-highest burden of the disease, with around 1.8 crore people with sickle cell traits and 14 lakhs with sickle cell disease.
The inherited disease runs from generation to generation. It is more widespread among the tribal population in India where about 1 in 86 births among them have the disease.
People who have the disease inherit two faulty genes — haemoglobin S, one from each parent; a person who has sickle cell trait inherits only one faulty gene.
PathoCatch Sickle Cell Rapid Test can be used in resource-limited regions with a high prevalence of the disease; and also in blood banks, gynaecology hospitals, primary/secondary health centres and government screening programmes, the company said.
The test kit will be available at hospitals and labs by the end of this month, it added.
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